Safety

A WELL DEFINED AND MANAGEABLE SAFETY PROFILE¹

*Patients who received one or more doses of study drug for either newly-diagnosed CP CML or were resistant or intolerant to prior therapy with CP, AP, BP CML or Ph+ ALL.
The data shown include real-world data in addition to safety data from the BFORE trial and Study 200.

1% of the overall patient safety population discontinued due to diarrhoea¹

NO NEW CARDIAC OR VASCULAR SAFETY SIGNALS AT 24 MONTHS IN NEWLY-DIAGNOSED PATIENTS²

*Patients who received one or more doses of study drug.

Please refer to the BOSULIF^® SmPC for full details of adverse events

AE, adverse event; ALL, acute lymphoblastic leukaemia; ALT, alanine aminotransferase; AP, accelerated phase; AST, aspartate aminotransferase; BP, blast phase; CML, chronic myeloid leukaemia; CP, chronic phase; Ph+, Philadelphia chromosome-positive; SmPC, Summary of Product Characteristics.

References

BOSULIF^® (bosutinib) Summary of Product Characteristics.
Cortes et al. Presented at American Society of Clinical Oncology Annual Meeting, 2018; Oral presentation 7002.

PP-BOS-GBR-0908. January 2020

Prescribing information

BOSULIF® (bosutinib) film-coated tablet containing 100 mg, 400 mg or 500 mg bosutinib (as monohydrate)

Legal category: Prescription only medicine. Basic NHS price: BOSULIF 100 mg, 28 tablets £859.17. BOSULIF 400 mg, 28 tablets £3,436.67. BOSULIF 500 mg, 28 tablets £3,436.67.

Click to access the BOSULIF 100 mg, 400 mg and 500 mg Summary of Product Characteristics hosted on Datapharm’s ‘electronic Medicines Compendium’.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.